Explain Quality Management System (QMS) for the uninitiated

John Predmore

Quite Involved in Discussions
#1
I was explaining to my coworkers how implementing a QMS is more than a checklist. (This is a small company, wanting to transition for the first time from a development firm to manufacturing a product for aerospace industry, desiring to become ISO certified). The quality standard is often perceived by the uninitiated as a checklist – if you have this verbiage in your procedures, if you show the auditor this evidence, he/she will mark you in compliance.

I explained that each of the elements of the quality standard should be thought of as a Plan->Do->Check->Act cycle. For the uninitiated, I explained P-D-C-A as Quality’s version of the Scientific Method (Hypothesis->Prediction->Experiment-> Act upon conclusion) which I hope is still taught in elementary school science class.

In this manner, every element in the standard is thought of as a continuous (and never-ending circular) process of Plan>Implement->Audit->Improve, which is analogous to P-D-C-A. Having a written Quality procedure is only the first tick-mark of the QMS continuum. To say a written procedure is fully implemented, it must also be in use, verified and shown to be effective.

I thought this comparison was a valuable explanation and I hope others find this analogy useful.

John
 
Elsmar Forum Sponsor
#2
that is correct and it seems under the right track to get a successful approach.
In the meantime, except for keep principles of the PDCA, we may consider the risk opportunity over the interaction of each procedure.
In order to learn the lesson, we may determine both check point and control point to secure the variation through the input + process + output in a procedure which is under the QMS with 3P product, process and people compliances.
 

stevegyro

Involved In Discussions
#3
that is correct and it seems under the right track to get a successful approach.

In the meantime, except for keep principles of the PDCA, we may consider the risk opportunity over the interaction of each procedure.

In order to learn the lesson, we may determine both check point and control point to secure the variation through the input + process + output in a procedure which is under the QMS with 3P product, process and people compliances.


Mr. Lin, very well stated! (I would like to work for you). Very few companies look at a process’ step input and correlation of output along with it’s associated variance. It would seem very relevant, and a time/resources saver. By truly understanding each process, the reaction plan becomes robust.

Thank you for reinforcing some key understandings (I rarely hear from others).

Steve Giarratana, Q.E.



Sent from my iPad using Tapatalk
 
Thread starter Similar threads Forum Replies Date
E Definition QUALITY 4.0 - Somebody here could explain the meaning of Quality 4.0? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
V Can you explain about "QUALITY FOUNDATION" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
A Please explain MDR Rule 11 to me EU Medical Device Regulations 67
R Explain what "design change" is to people new to the industry ISO 13485:2016 - Medical Device Quality Management Systems 9
Sidney Vianna Interesting Discussion Hello IAF. Are you listening? Please explain the inconsistency in your IAF Mandatory Documents (2019) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
I Trying to explain some of the Management Review Inputs (AS9100D) Management Review Meetings and related Processes 10
T From 21 CFR to IEC 60601 - Please explain IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E IATF 16949 Clause of 8.4.3 - Approvals - Can you explain to me IATF 16949 - Automotive Quality Systems Standard 1
J Please Recommend books that explain how to understand IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
M Please explain the following Automotive Acronyms IATF 16949 - Automotive Quality Systems Standard 3
M Help trying to explain accuracy procedure General Measurement Device and Calibration Topics 1
S Please explain Medical Device Product Classification Rationale 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Can anybody explain h.2 equation of GUM? Measurement Uncertainty (MU) 3
M Shewhart Control Chart for SPC In Excel - Explain the yellow and red marked column Statistical Analysis Tools, Techniques and SPC 2
S Class III Sampling Plan - Explain AQL vs. 95%C & 90%R Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
B AS 9104/1 - Can anyone briefly explain me what AS 9104/1 calls for? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B Please Explain Clause 8.3 in ISO 9001:2008 Nonconformance and Corrective Action 4
arios Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 4
A Customer Demands (MSA=Bias + GRR/2). Can somebody explain what it means? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
V Is there a form I can use to explain what I'm submitting PPAP for? APQP and PPAP 9
Sidney Vianna The GRI Report or Explain Campaign (Sustainable Development) Sustainability, Green Initiatives and Ecology 4
P EN ISO vs. ISO - Please explain to me EN ISO vs. ISO standards Other ISO and International Standards and European Regulations 3
R ISO 9001 and ISO 9004 - Can somebody briefly explain their difference? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Explain about fractional half 2^(k-1) and fractional quarter 2^(k-2) Using Minitab Software 1
A AQL Sample Sizes - Explain how Sample Sizes in an AQL table are calculated AQL - Acceptable Quality Level 4
L Please Explain Inspection Levels including C=0 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
D En 62366:2006 - Can someone explain what EN 62366:2006 covers? Other ISO and International Standards and European Regulations 3
J Please explain what formula is correct for "Mean and Range Control Chart" Statistical Analysis Tools, Techniques and SPC 1
V Define vs. Determine vs. Document - Explain ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Calibration vs. Inspection - Please explain the difference General Measurement Device and Calibration Topics 3
D Two Gauges (Gages) - Two measurements correlation I do not know how to explain Reliability Analysis - Predictions, Testing and Standards 4
R How would you explain DoF (Degrees of Freedom) to a non-statistician? Statistical Analysis Tools, Techniques and SPC 3
V The GM asked me to explain to the board about AQL (using layman terms). AQL - Acceptable Quality Level 11
F Explain the two different methods of coding of categorical predictors Software Quality Assurance 1
V Can you explain about "MATERIAL REVIEW BOARD" (MRB)? Misc. Quality Assurance and Business Systems Related Topics 13
Q REACH - Is it not the same as RoHS /IMDS? Can someone explain? RoHS, REACH, ELV, IMDS and Restricted Substances 1
B Recommendation for a book to Explain Control Charts Book, Video, Blog and Web Site Reviews and Recommendations 6
R Can you explain Six Sigma to me? Six Sigma 12
A Explain the meaning of 8.2.4 Monitoring and Measurement of Product AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
D How to Prove and Explain to Consultant (Internal Auditor) and Manager? Internal Auditing 7
P Criteria for operator's readings at setup - Seeking help to explain chosen limits. Statistical Analysis Tools, Techniques and SPC 4
A Theory of Constraints - Can anyone explain something? Six Sigma 6
Gert Sorensen Please explain to me what .asp does Software Quality Assurance 5
C Explain to me the differences between ISO9000 and TQM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Cpk Help needed - Explain to me where I made a mistake Capability, Accuracy and Stability - Processes, Machines, etc. 8
A Please explain to me in laymans terms how to calculate a single T-test Six Sigma 14
ScottK Can someone explain the marketing behind this ad? Coffee Break and Water Cooler Discussions 21
P Layered Process Audit & the Document Audit - Can anyone explain to me, Please? Process Audits and Layered Process Audits 2
Manix GM GP9 procedure - [email protected] - Can anybody explain the figure "% True Scrap"? Document Control Systems, Procedures, Forms and Templates 2
Similar threads


















































Top Bottom